Regeneron's Eylea clears first Phase III hurdle in diabetic retinopathy subset

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said Eylea aflibercept met the first of two primary endpoints in the Phase III PANORAMA trial to treat non-proliferative diabetic retinopathy without diabetic macular edema (DME). The company plans to submit an sBLA to FDA this year seeking to add the indication to Eylea's label.

The trial's two primary endpoints evaluated the proportion of patients with at least a two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) from baseline to weeks 24 and 52. Regeneron said 58% of patients receiving Eylea achieved the 24-week endpoint vs. 6% for sham injection (p<0.0001). The company said Eylea-treated patients received an average of 4.4 injections across 24 weeks...